Abstract 4310
Background
mSCPC is an orphan disease with a poor prognosis. First line systemic treatment relies on platinum-based polychemotherapies (PBPC). These combinations remain poorly effective with median progression-free survival (PFS) and overall survival (OS) around 7.5 months and 16 months respectively [Pagliaro 2010; Nicholson 2013]. SCPC is a disease with a virally induced oncogenesis, moreover PD-L1 is commonly expressed with an expression rate of 62.2% in primary tumours and a strong correlation between PD-L1 in the primary tumour and metastases [Udager 2016]. Immunotherapies targeting the PD-1/PD-L1 axis are effective in other squamous cell or HPV related cancers. There is no consensus on a second line systemic treatment in mSCPC. Tumour mass is assumed to be reduced as a result of the first line chemotherapy. PBPC are known to be able to trigger immunogenic cell death. The maintenance strategy after systemic chemotherapy which has controlled the disease is a validated concept in many tumour models. Maintenance treatment with immunotherapy after initial PBPC may help to maintain disease control in mSCPC setting.
Trial design
PULSE trial is a prospective multicenter open label phase II study that will enroll 32 patients. Patients with unresectable locally advanced or metastatic SCPC must have carried out a radiological assessment showing a non-progressive disease after 3 to 6 cycles of a first line PBPC. Patients previously treated by an immunotherapy are excluded. A minimal period of 3 weeks washout after chemotherapy is required before starting intravenous maintenance Avelumab. It will be administered every two weeks at the dose of 10mg/kg until progression or unacceptable toxicity. The primary objective is to assess PFS according to RECIST 1.1 criteria. Secondary objectives are overall survival, impact of PL-L1 expression, safety, quality of life. Exploratory endpoints include blood immune-response monitoring, correlation of tumour immune infiltrate and PD-L1 expression on PFS. Screening across ∼15 sites in France is being conducted with first site initiated in February 2019.
Clinical trial identification
NCT03774901.
Editorial acknowledgement
Legal entity responsible for the study
Thiery-Vuillemin.
Funding
Pfizer.
Disclosure
N. Gassian: Travel / Accommodation / Expenses: Ipsen; Travel / Accommodation / Expenses: Astellas; Travel / Accommodation / Expenses: Novartis Pharma SAS; Travel / Accommodation / Expenses: Pfizer. G. Mouillet: Travel / Accommodation / Expenses: Sanofi; Travel / Accommodation / Expenses: Ipsen; Travel / Accommodation / Expenses: Merck Serono; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: Janssen Cilag; Travel / Accommodation / Expenses: Bristol-Myers Squibb; Travel / Accommodation / Expenses: Astellas Pharma; Travel / Accommodation / Expenses: Pfizer. F. Calcagno: Travel / Accommodation / Expenses: Ipsen; Travel / Accommodation / Expenses: Bayer HealthCare SAS; Travel / Accommodation / Expenses: Pfizer; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: Bristol-Myers Squibb; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Sanofi. A. Thiery-Vuillemin: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Sanofi; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Ipsen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche/ Genentech; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy: Astellas Pharma. All other authors have declared no conflicts of interest.
Resources from the same session
3628 - Predictive model for survival in advanced non-small-cell lung cancer (NSCLC) treated with frontline pembrolizumab
Presenter: Xabier Mielgo Rubio
Session: Poster Display session 3
Resources:
Abstract
5705 - External validation and longitudinal extension of the LIPI (Lung Immune Prognostic Index) for immunotherapy outcomes in advanced non-small cell lung cancer.
Presenter: Jakob Riedl
Session: Poster Display session 3
Resources:
Abstract
5758 - Changes of TCR Repertoire in Metastatic Renal Cell Carcinoma and Metastatic Melanoma Patients Treated with Nivolumab
Presenter: Martin Klabusay
Session: Poster Display session 3
Resources:
Abstract
1743 - Expression of MHC class I, HLA-A and HLA-B identifies immune activated breast tumors with favorable outcome
Presenter: María Del Mar Noblejas López
Session: Poster Display session 3
Resources:
Abstract
2219 - Prognostic Significance of Tumor Tissue NeuGcGM3 Ganglioside Expression and Predictive Value of Circulating Tumor Cell Count Monitoring in Patients Receiving Racotumomab Immunotherapy
Presenter: Necdet Üskent
Session: Poster Display session 3
Resources:
Abstract
2996 - Evolution of Myeloid-Derived Suppressor Cells and Objective Response Rate in Relapsed/Refractory Diffuse Large B Cell Lymphoma (R/R DLBCL) patients after receiving immunotherapy
Presenter: Carlos Jiménez Cortegana
Session: Poster Display session 3
Resources:
Abstract
2110 - A Phase Ia/Ib trial of the anti-programmed death-ligand 1 (PD-L1) human monoclonal antibody (mAb), CS1001, in patients (pts) with advanced solid tumors or lymphomas
Presenter: Lin Shen
Session: Poster Display session 3
Resources:
Abstract
3515 - Results from a randomised Phase 1/2 trial evaluating the safety and antitumour activity of anti-PD-1 (MEDI0680)/anti-PD-L1 (durvalumab) vs anti-PD-1 (nivolumab) alone in metastatic clear cell renal cell carcinoma (ccRCC)
Presenter: Martin Voss
Session: Poster Display session 3
Resources:
Abstract
3566 - Pembrolizumab in Advanced Rare Cancers
Presenter: Aung Naing
Session: Poster Display session 3
Resources:
Abstract
3567 - High clinical benefit rates of pembrolizumab in very rare sarcoma histotypes: first results of the AcSé Pembrolizumab study
Presenter: Jean-Yves Blay
Session: Poster Display session 3
Resources:
Abstract